OncoMatch/Clinical Trials/NCT07428707
Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
Is NCT07428707 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Pirtobrutinib for chronic lymphocytic leukemia (cll).
Treatment: Pirtobrutinib — Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL. Objective: To test pirtobrutinib as a first-line treatment for CLL or SLL. Eligibility: People aged 18 years and older with untreated CLL or SLL. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue. Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles. Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months. Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits. A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug. Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research. Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Hemoglobin >= 8 g/dL (>= 80 g/L); ANC >= 0.75 x 10^9/L; Platelets >= 50 x 10^9/L; Hgb and platelets: independent of transfusions within 7 days of Screening assessment. ANC: independent of growth factor support within 7 days of Screening assessment.
Kidney function
Serum creatinine: Calculated creatinine clearance >= 30 ml/min according to Cockcroft/Gault Formula
Liver function
ALT or AST <= 3 x ULN or <= 5 x ULN with documented liver involvement; Total bilirubin <= 1.5 x ULN or <= 3 x ULN with documented liver involvement and/or Gilbert's Disease
adequate organ function for all of the following criteria, as defined below: Hepatic: ALT or AST <= 3 x ULN or <= 5 x ULN with documented liver involvement; Total bilirubin <= 1.5 x ULN or <= 3 x ULN with documented liver involvement and/or Gilbert s Disease. Renal: Serum creatinine: Calculated creatinine clearance >= 30 ml/min according to Cockcroft/Gault Formula. Hematologic: Hemoglobin >= 8 g/dL (>= 80 g/L); ANC >= 0.75 x 10^9/L; Platelets >= 50 x 10^9/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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